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In Vitro-In Vivo Correlation of Buprenorphine Transdermal Systems Under Normal and Elevated Skin Temperature
Sherin Thomas1, Dana C Hammell1, Hazem E Hassan1,2
1Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, 21201, USA.
Pharmaceutical Research
|April 24, 2023
Summary
Applying heat to buprenorphine patches (Butrans®) enhances drug delivery, confirmed by in vitro permeation tests. These studies correlate well with in vivo data, supporting the use of in vitro models for evaluating transdermal delivery systems.
Area of Science:
- Pharmacokinetics and Drug Delivery
- Transdermal Drug Delivery Systems
- Biopharmaceutics
Background:
- External heat application over buprenorphine transdermal systems (Butrans®) increases systemic drug levels.
- Understanding the in vitro-in vivo correlation is crucial for predicting transdermal system performance.
Purpose of the Study:
- To evaluate the correlation between in vitro permeation data and existing in vivo data for buprenorphine transdermal systems under varying temperatures.
- To assess the impact of elevated temperatures on buprenorphine permeation through human skin in vitro.
Main Methods:
- In vitro permeation tests (IVPT) were conducted using human skin from four donors.
- Skin temperature was maintained at either 32°C (normal) or 42°C (elevated) to simulate physiological conditions.
- The IVPT study design was harmonized with a previously published clinical study.
Main Results:
- In vitro studies demonstrated heat-induced enhancement in buprenorphine flux and cumulative permeation from Butrans®, consistent with in vivo findings.
- A Level A in vitro-in vivo correlation (IVIVC) was established using a unit impulse response deconvolution method.
- Prediction errors for AUC and Cmax were below 20%, indicating good correlation.
Conclusions:
- In vitro permeation studies under relevant temperature conditions can effectively evaluate the impact of external heat on transdermal delivery systems (TDS).
- IVPT studies provide a valuable tool for comparative assessment of heat effects on TDS performance.
- Further research is needed to explore factors beyond bioavailability that influence in vivo plasma exposure.
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